Arthritis KneePhase 4NCT03253224
Magnesium and Postoperative Pain
A Phase 4 study testing Magnesium Sulfate and Normal saline in people with Arthritis Knee and Magnesium Sulfate, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in particular, has been increasing with the growing demand for improved mobility and quality of life. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Arthritis Knee, Magnesium Sulfate, Dexmedetomidine
- What is being tested?
- Magnesium Sulfate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Sep 2017to 29 Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo total knee arthroplasty under spinal anesthesia
- Patients who want to sedation during the surgery
- American Society of Anesthesiologists physical status classification 1 and 2
Who cannot join
- General anesthesia
- Patients who do not want to sedation during the surgery
- Patients who do not receive patient controlled analgesia postoperatively
- Muscular disease
- Hypermagnesemia
- Atrioventricular block
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, 13620
About this study
Official title: The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Pain After Total Knee Arthroplasty in Patients Sedated With Dexmedetomidine Under Spinal Anesthesia: A Randomized-controlled Trial
With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in particular, has been increasing with the growing demand for improved mobility and quality of life. Total knee arthroplasty is performed on patients with advanced and painful osteoarthritis of the knees, but it can result in moderate to severe postoperative pain during the recovery period.
To relieve anxiety or stress during surgery under regional anesthesia, sedation can be provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor agonist, and its analgesic effect has been well established in various procedures or surgeries.
Magnesium has been reported to produce important analgesic effects including the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this study, investigators will evaluate the reducing effect of magnesium on the post-total knee arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.
- Conditions
- Arthritis Knee, Magnesium Sulfate, Dexmedetomidine
- Being tested
- Magnesium Sulfate, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery.
Normal salineDrug
Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Patient who received normal saline during the operation Receives: Drug: Normal saline |
| Magnesium | Experimental | Patient who received magnesium sulfate during the operation Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient controlled analgesia (PCA)
Amounts of PCA consumption
Measured: Postoperative 24 hour
Secondary outcomes (5)
Numerical rating scale
Postoperative pain score
Measured: Postoperative 24 hour
Rescue analgesics
Amounts of the analgesics administered to mange the postoperative pain
Measured: Postoperative 24 hour
Nausea
Incidence of nausea
Measured: Postoperative 24 hour
Vomiting
Incidence of vomiting
Measured: Postoperative 24 hour
Antiemetics
Amounts of antiemetics consumption
Measured: Postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start10 Sep 2017
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Why it stopped: Because the principle investigator will participate a visiting scholar program for one year in other country, this study has been terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Hyun-Jung Shin, Seoul National University Hospital
- Investigators
- Hyun-Jung Shin, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253224
- Sponsor's protocol ID
- B-1707/406-006
- Status last verified
- Dec 2017
- First submitted
- 15 Aug 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Pain After Total Knee Arthroplasty in Patients Sedated With Dexmedetomidine Under Spinal Anesthesia: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT03253224
- Acronym / sponsor ID
- B-1707/406-006
- Conditions
- Arthritis Knee, Magnesium Sulfate, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the principle investigator will participate a visiting scholar program for one year in other country, this study has been terminated.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in particular, has been increasing with the growing demand for improved mobility and quality of life. Total knee arthroplasty is performed on patients with advanced and painful osteoarthritis of the knees, but it can result in moderate to severe postoperative pain during the recovery period.
To relieve anxiety or stress during surgery under regional anesthesia, sedation can be provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor agonist, and its analgesic effect has been well established in various procedures or surgeries.
Magnesium has been reported to produce important analgesic effects including the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this study, investigators will evaluate the reducing effect of magnesium on the post-total knee arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: Normal salinePatient who received normal saline during the operation |
| Magnesium | Experimental | Drug: Magnesium SulfatePatient who received magnesium sulfate during the operation |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who undergo total knee arthroplasty under spinal anesthesia
- Patients who want to sedation during the surgery
- American Society of Anesthesiologists physical status classification 1 and 2
Key exclusion criteria (6 listed)
- General anesthesia
- Patients who do not want to sedation during the surgery
- Patients who do not receive patient controlled analgesia postoperatively
- Muscular disease
- Hypermagnesemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateMagnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery. | Drug | Magnesium |
| Normal salineNormal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group. | Drug | Saline |
Primary outcome
Patient controlled analgesia (PCA)
Time frame: Postoperative 24 hour
Amounts of PCA consumption
5 secondary outcomes
Numerical rating scale
Time frame: Postoperative 24 hour
Rescue analgesics
Time frame: Postoperative 24 hour
Nausea
Time frame: Postoperative 24 hour
Vomiting
Time frame: Postoperative 24 hour
Antiemetics
Time frame: Postoperative 24 hour
Results and safety
The study was stopped early (reason given: Because the principle investigator will participate a visiting scholar program for one year in other country, this study has been terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Arthritis Knee
Recruiting
Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
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Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
Not yet recruiting
Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
Knee Osteoarthritis
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Not yet recruiting
Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
Osteoarthritis, Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun-Jung Shin, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate and Normal saline in people with Arthritis Knee and Magnesium Sulfate, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Because the principle investigator will participate a visiting scholar program for one year in other country, this study has been terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient controlled analgesia (PCA) (time frame: Postoperative 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.